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Regulatory Oversight Artificial Intelligence Regulatory Requirements

Orrick, Herrington & Sutcliffe LLP

EU Commission – Guidelines on the Scope of the Obligation for GPAI Models under the AI Act

The European Commission published guidelines concerning the definition of “general-purpose AI models” (GPAI) under the AI Act and the scope of the Chapter V obligations imposed on providers of these models. The final...more

Venable LLP

HHS Finalizes Staffing Cuts, New CDER Director, CDER Hiring Data, and New AI Councils at FDA

Venable LLP on

Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency's structure and stakeholder interactions....more

Fisher Phillips

“Regulate AI Outcomes, Not AI Tools.” Congressman Shares Vision for AI Regulation + 5 Tips for Employers

Fisher Phillips on

Speaking at last week’s FP AI Conference, Congressman Jay Obernolte set out to debunk two misconceptions about artificial intelligence. The first is that AI is largely unregulated. The second is that we need to pass myriad...more

Mayer Brown

EU AI Act News: Rules on General-Purpose AI Start Applying, Guidelines and Template for Summary of Training Data Finalized

Mayer Brown on

Obligations relating to general-purpose artificial intelligence (“GPAI”) models under the EU AI Act enter into force on 2 August 2025. Ahead of this deadline, the European Commission (the “Commission”) has published a suite...more

Benesch

Dental/DSO Intelligence Monthly Report: July 2025

Benesch on

As government scrutiny of the healthcare industry intensifies, enforcement agencies are casting wider nets to recover funds based on narrowly interpreted violations. This puts not only healthcare providers but also those...more

Holland & Knight LLP

Podcast - Regulating AI in Healthcare: The Road Ahead

Holland & Knight LLP on

In this episode of "Counsel That Cares," Public Policy & Regulation attorney John Vaughan, Healthcare attorney Dan Silverboard and Public Affairs Advisor Sarah Starling Crossan discuss the rapidly evolving landscape of...more

WilmerHale

AI and GDPR: A Road Map to Compliance by Design - Episode 3: The Design Phase

WilmerHale on

The rise of artificial intelligence (AI) and its widespread availability offers significant growth opportunities for businesses. However, it necessitates a robust governance framework to ensure compliance with regulatory...more

WilmerHale

AI and GDPR: A Road Map to Compliance by Design - Episode 2: The Design Phase

WilmerHale on

The rise of artificial intelligence (AI) and its widespread availability offers significant growth opportunities for businesses. However, it necessitates a robust governance framework to ensure compliance with regulatory...more

Goodwin

Goodwin Antitrust & Regulatory Shorts: Three Laws, One challenge; Complying With the DSA, AI Act, and GDPR

Goodwin on

The Digital Services Act (DSA) and the Artificial Intelligence Act (AI Act) are key components of the EU’s constantly evolving, digital regulatory landscape. Once forming policy proposals, both regulations have now evolved...more

Hogan Lovells

AI wellness or regulated medical device? A lawyer's guide to navigating FDA rules—and what could change next

Hogan Lovells on

As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that launch with the best of...more

Morgan Lewis

Navigating Uncertainty in US FDA’s Center for Devices and Radiological Health Regulation of Medical Devices

Morgan Lewis on

The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Texas Takes a Shot at AI Regulation With ‘Responsible Artificial Intelligence Governance Act’

On June 22, 2025, Texas became the latest state to enact comprehensive AI legislation with a uniquely Texan twist through the passage of the Texas Responsible Artificial Intelligence Governance Act....more

Kilpatrick

Texas Enacts Texas Responsible Artificial Intelligence Governance Act

Kilpatrick on

On June 22, 2025, Texas Governor Greg Abbott signed the Texas Responsible AI Governance Act (TRAIGA) into law. While earlier versions of the bill mirrored broader frameworks like the EU AI Act, the final version scales back...more

McDermott Will & Schulte

Partnering with Legal at the Critical AI/Healthcare Crossroads

The intersection of AI and healthcare is outpacing the development of laws and regulations governing the technology. Even in the early days of AI transformation, this is creating uncertainty for healthcare organizations....more

Wilson Sonsini Goodrich & Rosati

Nevada Passes Law Limiting AI Use for Mental and Behavioral Healthcare

On June 5, 2025, Nevada Governor Joe Lombardo signed AB 406, a law regulating the use of artificial intelligence (AI) for mental and behavioral healthcare. AB 406 comes as other states, such as Utah and New York, have taken...more

DLA Piper

Texas Adopts the Responsible AI Governance Act

DLA Piper on

On June 22, 2025, Governor Abbott signed HB 149, the “Texas Responsible Artificial Intelligence Governance Act” (the Act or TRAIGA), making Texas the third US state, after Colorado and Utah, to adopt a comprehensive...more

Morgan Lewis - As Prescribed

Key Takeaways from the AI Trends in Medical Devices Panel at the 2025 FDLI Annual Conference

Ariel Seeley served on the panel titled AI Trends in Medical Devices: Global Developments, FDA Policies, and Software as a Medical Device at the 2025 Food and Drug Law Institute (FDLI) Annual Conference. The panel provided an...more

White & Case LLP

AI Watch: Global regulatory tracker - Brazil (UPDATED)

White & Case LLP on

Brazil intends to regulate AI through Bill No. 2,338/2023 ("Brazil's Proposed AI Regulation"), although there are currently no specific codified laws, statutory rules or regulations in Brazil that directly regulate AI....more

Arnall Golden Gregory LLP

FDA in the “Computer Age” — AI Adoption Accelerates as Staffing Shrinks

Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial intelligence (“AI”) in the face...more

Foodman CPAs & Advisors

The Compliance Gap in AML AI: Why Audit-Ready Tools Matter

icraAs artificial intelligence reshapes financial compliance practices, regulators across Latin America and globally are increasing their scrutiny of AI-based AML tools. This article explores the growing audit gap, and what...more

Morgan Lewis - As Prescribed

FDA’s AI-Assisted Review: The Next Stage of Regulated Product Evaluation

On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes agency functions and...more

IR Global

Recursive Artificial Intelligence: Can the Law Keep Up?

IR Global on

While Artificial Intelligence (AI) has emerged as groundbreaking and significantly impacting various sectors and enhancing quality of life, the chasm between technological advancements and the law is growing by the...more

Smart & Biggar

CDA update: new five-year strategic plan and position statement on using AI in health technology assessments

Smart & Biggar on

On April 15, 2025, Canada’s Drug Agency (CDA) released its new five-year strategic plan, Insight to Impact 2025-2030. Formerly the Canadian Agency for Drugs and Technologies in Health (CADTH), this is the CDA’s first...more

Gardner Law

FDA Goes All In on AI: What It Means for Your Submissions

Gardner Law on

The FDA is moving quickly to bring artificial intelligence (AI) into the heart of its regulatory review process. On May 8, 2025, the agency announced the successful completion of its first AI-assisted scientific review—and...more

Alston & Bird

5 Things to Think About When Using AI

Alston & Bird on

What Happened? As the Trump Administration’s deregulatory, pro-innovation approach to emerging technology moves forward, the use of artificial intelligence has taken center stage, and it is clear that the Administration...more

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